CompletedNot Applicable

Learning and Relapse Risk in Alcohol Dependence (FP2)

Germany258 participantsStarted 2015-04

Plain-language summary

The investigators will examine clinical alterations in learning and automated approach behaviour and their neurobiological correlates in alcohol-dependent patients and healthy social drinkers and assess whether they are affected by a Zooming Joystick Training (ZJT; randomized "verum" versus "placebo" training) which trains subjects to habitually push alcohol pictures away. The investigators will test whether activations following treatment predict relapse rate (primary outcome measure) and the prospective amount of alcohol intake (secondary outcome measure) within a six-month follow-up period. Using fMRI, the investigators will use the Pavlovian-to-Instrumental-Transfer (PIT) paradigm established during the first funding period to distinguish the effects of appetitive, aversive, and drug-related Pavlovian cues on automated instrumental approach behaviour and to assess ZJT training effects comparing functional activation before and after ZJT training. The investigators will also scan subjects during performance of a short standard working memory task. Behaviourally, aspects of impulsivity will be assessed with the Value-Based Decision Making (VBDM) Battery. Scanning will be repeated after ZJT training to assess its effects on the neural correlates of Pavlovian-to-Instrumental transfer (PIT).

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women aged 18-65 years * alcohol dependence/alcohol use disorder according to ICD-10 and alcohol-use disorder according to DSM-5 * Minimum of 72 hours of abstinence, maximum of 21 days of abstinence * Minimum of three years with alcohol dependence/alcohol use disorder * Low severity of withdrawal symptoms * Ability to provide fully informed consent and to use self-rating scales * Sufficient understanding of the German language Exclusion Criteria: * Lifetime history of DSM-IV bipolar, psychotic disorder, or substance dependence other than nicotine dependence. Patients may have had lifetime alcohol dependence/alcohol use disorder diagnoses. * Current threshold DSM-IV diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder * History of substance dependence other than alcohol or nicotine dependence * Current substance use other than nicotine and alcohol as evinced by positive urine test * History of severe head trauma or other severe central neurological disorder (dementia, Parkinson's disease, multiple sclerosis) * Pregnancy or nursing infants * Any alcohol intake within the last 24 hours * Use of medications or drugs known to interact with the central nervous system within the last 10 days, except detoxification treatment with benzodiazepines or clomethiazole, with testing at least four half-lives pos…

What they're measuring

relapse to heavy drinking

Timeframe: 6 months

Trial details

NCT IDNCT02615977

SponsorTechnische Universität Dresden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08